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Standards UNE - Spanish national standards - Page 179
Spanish national standards UNE are published by the company AENOR, which deals with the development of national standardization and certification in all industrial and services sectors. Its aim is to contribute to the quality, competitiveness and improvement of companies and to protect the environment.
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UNE-EN ISO 11607-1:2020/A11:2022
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Change published on 21.12.2022
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UNE-EN ISO 11607-2:2020
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Standard published on 23.9.2020
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UNE-EN ISO 11607-2:2020/A1:2024
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
Change published on 22.5.2024
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UNE-EN ISO 11607-2:2020/A11:2022
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Change published on 21.12.2022
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UNE-EN ISO 11608-1:2022
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Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2022) (Endorsed by Asociación Espanola de Normalización in July of 2022.)
Standard published on 1.7.2022
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UNE-EN ISO 11608-2:2022
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Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022) (Endorsed by Asociación Espanola de Normalización in July of 2022.)
Standard published on 1.7.2022
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UNE-EN ISO 11608-3:2022
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Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01)
Standard published on 1.7.2022
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UNE-EN ISO 11608-4:2022
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Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022, Corrected version 2024-12)
Standard published on 1.7.2022
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UNE-EN ISO 11608-5:2023
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Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
Standard published on 4.10.2023
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UNE-EN ISO 11608-7:2018
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Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
Standard published on 24.1.2018
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